Carnitine Supplementation and Bone Mineral Density
Effect of Carnitine Supplementation and Resistance Training on Bone Mineral Density
1 other identifier
interventional
36
1 country
1
Brief Summary
The primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women. A secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 7, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 7, 2018
CompletedFirst Submitted
Initial submission to the registry
November 3, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedAugust 16, 2022
August 1, 2022
10 months
November 3, 2021
August 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Bone Mineral Density measured by dual-energy X-ray absorptiometry (DXA)
Bone mineral density (BMD) of the femoral neck, lumbar vertebrae L1-L4, and total hip determined by Lunar Prodigy Advance DXA (GE, Healthcare, Madison, Wisconsin, USA).
24 weeks
Secondary Outcomes (2)
Body Composition: Body Fat Mass, Fat Free Mass, and Skeletal Muscle Mass using a bioelectrical impedance analyzer (InBody720).
24 weeks
The circulating markers modification
24 weeks
Study Arms (2)
carnitine + leucine
EXPERIMENTAL1000 mg L-carnitine with 3000 mg L-leucine per day for 24 weeks
leucine
PLACEBO COMPARATOR4000 mg L-leucine per day for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- postmenopausal
- lack of restrictions to perform resistance exercises
You may not qualify if:
- cardiovascular disease
- liver disease
- kidney disease
- neuromuscular disease
- gastrointestinal disorders (including stomach ulcers and erosions)
- diabetes
- other severe chronic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Akademia Wychowania Fizycznego
Poznan, 61-871, Poland
Related Publications (1)
Olek RA, Samborowska E, Wisniewski P, Wojtkiewicz P, Wochna K, Zielinski J. Effect of a 3-month L-carnitine supplementation and resistance training program on circulating markers and bone mineral density in postmenopausal women: a randomized controlled trial. Nutr Metab (Lond). 2023 Aug 2;20(1):32. doi: 10.1186/s12986-023-00752-1.
PMID: 37533033DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Olek, PhD
Poznan University of Physical Education
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 3, 2021
First Posted
November 15, 2021
Study Start
September 1, 2017
Primary Completion
July 7, 2018
Study Completion
July 7, 2018
Last Updated
August 16, 2022
Record last verified: 2022-08